Summary

The purpose of this study is to determine whether intracoronary transfer of autologous bone
marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion,
and finally resulting in improved systolic and diastolic left ventricular function in
patients with myocardial infarction.

Study Design

Primary Outcomes

Measure

Changes in left ventricular ejection fraction from baseline to 6 months' follow-up

time frame:
3 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria:
1. Patients with coronary disease undergoing CABG.
2. At least 3 months since last episode of myocardial infarction
3. Patients fulfilling either of the following criteria based on the extent of CAD by
coronary angiography and LVEF by echocardiography.
Reversible myocardial ischemia as revealed by SPECT. ejection fraction >=40% <=50%.
Age >=18 years and <=70 Patients who can give informed consent themselves in writing.
4. Negative pregnancy test (in women with childbearing potential).
Exclusion Criteria:
Any one of the following exclusion criteria is sufficient to disqualify a patient from the
study.
1. Sustained ventricular tachycardia in a 24-hour ECG.
2. Chronic atrial fibrillation.
3. Less than 3 months since last episode of cerebral infarction.
4. Patients with a malignant tumor*.
5. Patients with chronic rheumatoid arthritis.
6. Patients with a history of severe allergic reactions.
7. Patients with hematological disease (leukemia, myeloproliferative disease, or
myelodysplastic syndromes).
8. Patients currently suffering from or having a history of interstitial pneumonitis.
9. Leukocytes less than 4,000/µL or exceeding 10,000/µL.
10. Platelets less than 100,000/µL.
11. Hemoglobin less than 10 g/dL.
12. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
13. Patients for whom it is impossible to perform both cardiac MRI
14. Pregnant or nursing patients, those who may be pregnant, or those who plan on
becoming pregnant before the end of the study period.
15. Any other reason that the Clinical Supervisors or Clinical Researchers may have for
considering a case unsuitable for the study.

Additional Information

Description

This research study is being performed to find out more information about the safety and
efficacy of autologous bone marrow stem cells transplantation. In patients with myocardial
infarction, the heart muscle does not pump well. Over a period of years, this continues to
get worse until the patient dies of heart failure. The researchers are trying to find out if
the transplantation of these stem cell can make a change in the functioning of these areas
of the heart muscle.
Patients between 18 and 70 years of age who received autologous bone marrow stem cell
transplant at the Fuwai cardiovascular hospital may be eligible for this study. Candidates
must have had their first transplant at least 3 years before entering the current study.
These patients receive autologous bone marrow cells transplantation intracoronary undergoing
Coronary Artery Bypass Graft. The objective evaluations will be performed at baseline and
during 6 months follow-up.
Heart function tests may include the following:
1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes
placed on the chest transmit information from the heart to a machine.
2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of
the heart and examine the function of the heart chambers and valves.
3. Gated acquisition scan is a nuclear medicine test that uses a small amount of
radioactive chemical injected into a vein. A special scanner creates an image of the
heart for examining the beating motion of the muscle.
4. MRI evaluates function of the heart chambers the beating motion of the muscle.

Trial information was received from ClinicalTrials.gov and was last updated in October 2008.

Information provided to ClinicalTrials.gov by China National Center for Cardiovascular Diseases.